Allura Xper and Azurion Systems
Last updated
Summary
Product
Allura Xper and Azurion Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Allura Xper FD10 (Product Of AlluraClarity Family) | Not applicable. | 722026 |
| Allura Xper FD10/10 (Product Of AlluraClarity Family) | Not applicable. | 722027 |
| Azurion 7 M20 | Not applicable. | 722 224 |
| Azurion 7 M20 | Not applicable. | 722 079 |
| Azurion 7 M20 | Not applicable. | 722234 |
| Allura Xper FD20/15 | Not applicable. | 722058 |
| Allura Xper FD10 | Not applicable. | 001443 |
| Allura Xper FD20/10 (Product Of AlluraClarity Family) | Not applicable. | 722029 |
| Azurion 7 M12 | Not applicable. | 722233 |
| Azurion 7 M12 | Not applicable. | 722 223 |
| Azurion 7 M12 | Not applicable. | 722 078 |
| Azurion 3 M12 | Not applicable. | 722 063 |
| Azurion 3 M12 | Not applicable. | 722 221 |
| Azurion 3 M12 | Not applicable. | 722229 |
| Azurion 5 M12 | Not applicable. | 722 227 |
| Azurion 5 M12 | Not applicable. | 722231 |
| Azurion 5 M20 | Not applicable. | 722 228 |
| Azurion 5 M20 | Not applicable. | 722232 |
| Allura Xper FD20 (Product Of AlluraClarity Family) | Not applicable. | 722028 |
| Allura Xper FD20/20 (Product Of AlluraClarity Family) | Not applicable. | 722038 |
| Azurion 7 B20 | Not applicable. | 722 226 |
| Azurion 7 B20 | Not applicable. | 722236 |
| Azurion 7 B20 | Not applicable. | 722 068 |
| Azurion 3 M15 | Not applicable. | 722230 |
| Azurion 3 M15 | Not applicable. | 722 064 |
| Azurion 3 M15 | Not applicable. | 722 222 |
| Azurion 7 B12 | Not applicable. | 722 067 |
| Azurion 7 B12 | Not applicable. | 722235 |
| Azurion 7 B12 | Not applicable. | 722 225 |
| Allura Xper FD20 Or Table (Product Of AlluraClarity Family) | Not applicable. | 722035 |
Issue
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch due to:
- cable or connector damage (internal and/or external)
- internal microswitch failure (each foot switch pedal activates two independent microswitches that - when both activated - release X-ray)
- foot switch connector issues resulting from missing or incorrectly applied strain relief
No or intermittent X-ray could potentially result in a delay or abort of procedure.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
| Philips Medical Systems Nederland B.V. |
| Veenpluis 6, Best, Netherlands, 5684 PC |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81765
Get notified
Receive emails about new and updated recall and safety alerts.